Technical Writer

3 weeks ago

Mississauga, Canada Bora Pharmaceutical Services Full time

**Location**:

- Mississauga, ON**Date Posted**:

- 3/13/2024**Job Number**:

- JO-2403-1681- Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories. At Bora, we insist on high quality, reliability, and efficiency without any compromises. Dedication to these high standards is how we create a long-lasting company culture that is the bedrock for our growth.
- We cover the entire pharmaceutical supply chain from research and development to sales and distribution. We focus on manufacturing and selling generic, brand, and over-the-counter (OTC) drugs to clients around the world.
- **Why join Bora?**
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym and basketball court

**TITLE**: Technical Writer
- **DEPARTMENT**: IDTS
- **POSITION REPORTING TO**: Technical Transfer Manager
- **THIS IS A FULL TIME CONTRACT POSITION**

**General Description**:
The Technical Writer is responsible for crafting and updating cGMP (Current Good Manufacturing Practices) documentation for the IDTS department, both for processes and equipment, including standard operating procedures, work instructions, master batch records and general administrative procedures.**Responsibilities**:

- Documentation Architecture: Develop and implement an efficient documentation architecture for the manufacturing and packaging processes within the department.
- Documentation Creation: Demonstrated ability to develop and maintain clear, concise, and compliant documentation, including standard operating procedures (SOPs), work instructions, forms, reports, Batch Records, and protocols, following Good Documentation Practices (GDP) principles.
- Quality: Review and revise documents for accuracy, completeness, and compliance with regulatory requirements as needed. Implement version control and change management processes. Writing technical investigations and deviation reports when required.
- Cross-functional Collaboration: Work closely with various departments, including, Quality Assurance, Manufacturing, and Environment Health& Safety (EHS) to gather information and improve documentation processes.
- Continuous Improvement: Demonstrated ability to identify opportunities to streamline documentation processes, improve document accessibility, and enhance overall efficiency in alignment with Lean Management principles; lead and execute those improvements to completion. Proactively identify and improve inefficient processes.
- Technical Writing Standards: Uphold high standards of technical writing, ensuring documents are clear, concise, and easily comprehensible by the intended audience. Review documents for logic, clarity, comprehensiveness, relevance and organization, format, flow, grammar, punctuation, and spelling for compliance with customer standards, style guidance, and publication policies. Able to distill complex terms into something simple, visual and easily comprehendible.
- Observes and supports all safety guidelines and regulations.
- Follows GMP and regulatory requirements, and ensures quality standards are met.

**Qualifications (Experience and Skills)**:

- 3+ years of industry experience working with Good Documentation Practices (GDP) in a relevant industry (Pharmaceutical or Biotechnology preferred).
- Proven experience as a technical writer with a strong understanding of Good
- Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
- Experience in creation and revision with both paper based, and electronic versions of Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs) or electronic Batch Records (eBR).
- Knowledge of Good Manufacturing Practices and CA/US/EU regulations.
- Excellent oral and written communication.
- Excellent computer skills.
- Proven ability to manage tasks and meet timelines.
- Is a team player and can work across all levels and functions.
- Well-developed multitasking abilities and strong collaborative skills

**Education**:
Required:

- Minimum Bachelor of Sciences in Chemistry or equivalent experience in the pharmaceutical industry

**WORKING CONDITIONS**
- Office environment, occasionally into production area

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